Sometimes, India has exported more pharmaceutical products than it imports. The pricing methods for imported bulk drugs were based on the landed cost including import & customs duty, which was the maximum permissible selling price. All drugs to be imported require their own import registration. Demand in India is growing rapidly due to rising population, increasing elderly people. So, importing medicines is expected to rise strongly.
Government of India, Ministry of Health and Family Welfare has published a Gazette Notification GSR no. 604 (E) dated 24.08.2001 amending the various provisions of the Drugs & Cosmetics Rules, thereby introducing a new provision for the registration of the manufacturing premises of foreign drug manufacturer and the individual drugs prior to their import into India. The notification has also introduced few other provisions viz. enhanced import license fees, increased validity period of license, deletion of exemption from requirement of import license for bulk drugs for actual users, requirement of minimum 60% of shelf life for imported drugs and provisions for import of small quantities of new drugs by Govt. hospitals for treatment of their own patients etc.
According to new rules, import license will be required for all types of drugs instead of existing import license requirements for Schedule C & C (1) and Schedule X drugs only. Import license in Form- 10 would be granted after completing the registration of overseas manufacturers and their specific drugs to be imported.
'Import license' means a license to import drugs, excluding those specified in Schedule X, or a license in to import drugs specified in Schedule X); A separate provision has been made to enable the Govt. hospitals to import small quantities of essential new drugs for the treatment of their own patients.
ACPL’s aim is to provide regulatory assistance to its Clients to get products registered, to get Import License of notified medical devices in India by applying in Form-8 along with Form -9.
Validity of import license for specific drugs
The import license for specific drugs will be valid for 3 years from the date on which these are granted. The import license fee has been kept Rs. 1000/- for a single drug and at the rate of Rs.100/- for additional drug. The fee of import licenses for test and analysis of a drug has been kept Rs. 100/- for a single drug and at the rate of Rs. 50/- for each additional drug.
Exemptions from import license
The exemption from import licenses for the import of bulk drugs by the formulations for actual use under Schedule D has been deleted. A provision has been made that only drugs with minimum 60% of retained shelf life shall be allowed to be imported in the country.
A separate provision has been made to enable the Govt. hospitals to import small quantities of essential new drugs for the treatment of their own patients. The fee for such import licenses has been kept Rs. 100/- for a single drug and the rate of Rs. 50/- for each additional drug.
The copy of the Drugs & Cosmetic Act 1940 & Rules 1945 are available in the CDSCO web page under link http://cdsco.nic.in